Quality Assurance Specialist

• Conduct calibration monitoring on calibrated equipment
• Maintain and support the company's quality management system in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements
• Create, revise, and maintain quality documentation, including work instructions, inspection checklists, SOPs, and inspection records
• Support internal and external audits by preparing documentation and evidence of compliance
• Assist with supplier and vendor quality evaluations as needed
• Initiate and track non-conformance reports and coordinate root cause analysis with relevant departments
• Support the corrective and preventive action process, tracking action items through to closure
• Escalate recurring or high-risk quality issues to the Quality Manager and relevant department leads
• Track and report quality metrics, including defect rates, inspection results, and CAPA status, to management
• Recommend process improvements to reduce defects, rework, and returns
• Participate in cross-functional meetings with Operations, Technical Support, and Sales to communicate quality trends and risks
• Perform other duties as assigned based on business needs

• High school diploma or GED required
• 2–3+ years of experience in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment
• Working knowledge of quality management systems and inspection documentation practices
• Ability to read and interpret technical specifications, schematics, and work instructions
• Strong attention to detail and accurate record-keeping skills
• Effective written and verbal communication skills for documenting findings and collaborating across teams
• Must be able to travel 10%-15% (at least once per quarter)
• Experience with ISO 13485 or FDA 21 CFR Part 820 quality systems preferred
• ASQ certification (CQA, CQT, or CQI) or equivalent preferred
• Experience with medical device refurbishment, biomedical equipment, or healthcare technology preferred
• Familiarity with CAPA and non-conformance preferred
• Experience with EQMS preferred

Demonstrates expertise in quality management systems, particularly ISO 13485 and FDA QSR compliance, with a strong focus on documentation practices and quality metrics tracking. Capable of conducting audits, managing non-conformance reports, and collaborating across departments to enhance quality processes.

• ISO 13485 Compliance
• Quality Management Systems
• Non-Conformance Reporting
• CAPA Process Management
• ASQ Certification

• Quality Assurance
• Quality Control
• Inspection Documentation
• Root Cause Analysis
• Defect Rate Tracking
• Technical Specification Interpretation
• SOP Creation
• Quality Metrics Reporting
• Regulatory Compliance
• Medical Device Quality Standards

• Attention to Detail
• Effective Communication
• Collaboration
• Problem-Solving
• Record-Keeping

• ASQ CQA
• ASQ CQT
• ASQ CQI

• Medical Devices
• Regulated Manufacturing
• Biomedical Equipment
• Healthcare Technology
• Electronics

• EQMS
• Inspection Checklists
• Work Instructions
• Quality Documentation